Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma - Trial NCT04314843
Access comprehensive clinical trial information for NCT04314843 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Kite, A Gilead Company and is currently Not yet recruiting. The study focuses on Relapsed/Refractory Large B-cell Lymphoma. Target enrollment is 6 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Kite, A Gilead Company
Gilead Sciences
Timeline & Enrollment
Phase 1/2
May 26, 2020
Mar 01, 2022
Primary Outcome
For Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy with Lenzilumab and Axicabtagene,For Phase 2: Percentage of Participants Experiencing Grade 2 or Higher Neurologic Events Within 28 days of Axicabtagene Ciloleucel Administration
Summary
The primary objectives of this study are:
 
 Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene
 ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the
 most appropriate dose of lenzilumab for Phase 2.
 
 Phase 2: To evaluate the incidence of neurologic events with sequenced therapy given at the
 recommended Phase 2 dose (RP2D) of lenzilumab in participants with relapsed or refractory
 large B-cell lymphoma.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04314843
Non-Device Trial